Ammon Pinizzotto Center for Women's Mental Health, Massachusetts General Hospital, Boston, Massachusetts, USA.
Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
J Womens Health (Larchmt). 2023 Apr;32(4):452-462. doi: 10.1089/jwh.2022.0310. Epub 2023 Jan 30.
Second-generation antipsychotics (SGAs), also called atypical antipsychotics, are common therapies for women with a spectrum of psychiatric disorders. No systematically ascertained human reproductive safety data are available for lurasidone, and prospective data for quetiapine are limited, making decisions regarding use of these medications during pregnancy complicated. The National Pregnancy Registry for Psychiatric Medications is a prospective cohort study designed to collect reproductive safety data relative to SGAs. Pregnant women aged 18-45 years, with psychiatric illness and prenatal psychotropic medication exposure completed three phone interviews during pregnancy and the postpartum period. Cases of presumed malformations are abstracted from medical records for adjudication by a teratologist blinded to medication exposure. Of 2,293 women enrolled at the time of analysis, 134 in the lurasidone group, 264 in the quetiapine group, and 886 controls completed the postpartum interview and were therefore eligible for inclusion. Dropped or lost-to-follow-up participants (13%) and those currently pregnant were excluded. Participants were predominantly White, college-educated, and married (lurasidone = 88.1%, 76.9%, 77.6%; quetiapine = 89.8%, 71.2%, 75.0%; controls = 92.7%, 86.7%, 89.1%). Absolute risks of major malformations were 2.19% (lurasidone), 1.85% (quetiapine), and 1.77% (controls). Odds ratios comparing lurasidone and quetiapine with controls were 1.24 (95% confidence interval [CI] = 0.36-4.32) and 1.04 (95% CI = 0.38-2.85), respectively. No specific patterns of malformations were observed in infants exposed to the medications of interest. Lurasidone and quetiapine did not appear to be major teratogens, but further information is needed to refine risk estimates. Food and Drug Administration guidance underscores the importance of pregnancy registries. Clinical trial number: NCT01246765.
第二代抗精神病药物（SGAs），也称为非典型抗精神病药物，是治疗各种精神疾病女性的常用疗法。目前尚无可供系统确认的卢拉西酮人类生殖安全性数据，喹硫平的前瞻性数据也有限，这使得在怀孕期间使用这些药物的决策变得复杂。国家精神药物妊娠登记处是一项前瞻性队列研究，旨在收集与 SGA 相关的生殖安全性数据。年龄在 18-45 岁之间、患有精神疾病且在怀孕期间使用过精神药物的孕妇在怀孕期间和产后期间完成了三次电话访谈。从病历中提取疑似畸形病例，由一名对药物暴露情况不知情的畸形学家进行裁决。 在分析时，共有 2293 名女性入组，其中卢拉西酮组 134 名，喹硫平组 264 名，对照组 886 名完成了产后访谈，因此有资格入组。脱落或失访者（13%）和目前怀孕者被排除在外。参与者主要为白人、受过大学教育且已婚（卢拉西酮组=88.1%、76.9%、77.6%；喹硫平组=89.8%、71.2%、75.0%；对照组=92.7%、86.7%、89.1%）。主要畸形的绝对风险分别为 2.19%（卢拉西酮）、1.85%（喹硫平）和 1.77%（对照组）。与对照组相比，卢拉西酮和喹硫平的比值比分别为 1.24（95%置信区间[CI] = 0.36-4.32）和 1.04（95%CI = 0.38-2.85）。在暴露于研究药物的婴儿中，没有观察到特定的畸形模式。卢拉西酮和喹硫平似乎不是主要的致畸剂，但需要进一步的信息来完善风险估计。食品和药物管理局的指导强调了妊娠登记处的重要性。临床试验编号：NCT01246765。
